Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy |
| Enrollment: | 18 |
| Study Start Date: | May 2000 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.
- Determine objective response, duration of response, and time to progression in these patients when treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic breast cancer
Bidimensionally measurable disease
- At least one lesion at least 2 cm in one dimension by CT scan or MRI
Must have failed prior anthracycline/taxane based chemotherapy as defined by one of the following:
- Stage IV disease treated with anthracycline/taxane combination as first line therapy for advanced or metastatic disease
- Stage IV disease treated with first line anthracycline therapy and second line taxane therapy for advanced or metastatic disease
- Any adjuvant treatment other than anthracycline based therapy followed by anthracycline/taxane combination as first line therapy for advanced or metastatic disease
- Any adjuvant therapy other than anthracycline based therapy followed by first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
- Adjuvant anthracycline based therapy followed by relapse after 6 months treated with anthracycline/taxane combination as first line therapy or first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
- Adjuvant anthracycline based therapy followed by relapse within 6 months treated with first line taxane based therapy for advanced or metastatic disease
- Disease progression within 6 months of last taxane based chemotherapy
- No brain metastases
Hormonal receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of liver metastases)
Renal:
- Creatinine less than 1.25 times ULN
Cardiovascular:
- LVEF at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin 900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater
- No prior or active congestive heart failure, myocardial infarction, or angina
- No uncontrolled hypertension or arrhythmia
Other:
- No unstable systemic disease
- No active infection
- No grade 2 or greater peripheral neuropathy
- No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior high dose chemotherapy with hematopoietic rescue
- No concurrent immunotherapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) for prevention of neutropenia
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 1 prior taxane based chemotherapy for advanced or metastatic disease
- No prior high dose chemotherapy with hematopoietic rescue
- No prior platinum based chemotherapy
- No prior taxane chemotherapy other than docetaxel or paclitaxel
- No prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination chemotherapy
Endocrine therapy:
- No concurrent steroids except in case of allergy prevention, emesis prophylaxis, or long term treatment for more than 3 months prior to study
- No concurrent hormonal anticancer therapy
Radiotherapy:
- No prior radiotherapy to study site unless evidence of disease progression
- Concurrent local radiotherapy allowed for pain relief
Surgery:
- At least 4 weeks since prior major surgery
Other:
- At least 4 weeks since prior anticancer and/or investigational drug
- No concurrent bisphosphonates unless started at least 2 months prior to study
- No other concurrent anticancer therapy
- No other concurrent experimental drugs
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna (Wien), Austria, A-1100 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels (Bruxelles), Belgium, 1000 | |
| France | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Germany | |
| Universitats-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Schneider Children's Medical Center of Israel | |
| Petah-Tikva, Israel, 49202 | |
| Slovenia | |
| Institute of Oncology, Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00006121 History of Changes |
| Other Study ID Numbers: | EORTC-16001-10005, EORTC-16001 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage III breast cancer stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013